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A Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh (CABS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01749982
Recruitment Status : Completed
First Posted : December 17, 2012
Results First Posted : August 28, 2014
Last Update Posted : August 28, 2014
Information provided by (Responsible Party):
Megan Hall, Columbia University

Brief Summary:

Roughly 140 million people worldwide are chronically exposed to As-contaminated drinking water at concentrations exceeding the World Health Organization (WHO) standard of 10 µg/L. Arsenic is a class I carcinogen known to cause several types of cancer and ischemic heart disease. Metabolism of inorganic As (InAs), which facilitates urinary As excretion, relies on one-carbon metabolism and involves two methylation steps; both utilize S-adenosylmethionine (SAM) as the methyl donor. SAM biosynthesis relies on B vitamins including folate and B12 for the recruitment and transfer of methyl groups, but other nutrients, including choline and betaine, also contribute to the methyl pool. Our recent findings from a cross-sectional study of Bangladeshi adults exposed to a wide range of As concentrations in drinking water show that plasma choline and betaine concentrations are positively associated with As methylation. These findings suggest that choline and/or betaine may play an important role in As methylation and elimination and that simple interventions may have therapeutic potential for the many populations at risk for As-induced health effects.

The investigators aim to recruit and follow 60 participants for this pilot study which will allow us to 1) assess the acceptance of choline and betaine supplements, 2) monitor participants for any potential side effects, 3) identify any difficulties that might be encountered in daily follow-up, and 4) generate preliminary data regarding the effects of choline and/or betaine supplementation on arsenic methylation.

Condition or disease Intervention/treatment Phase
Arsenic Metabolites Measured in Urine Other: Placebo Drug: Choline bitartrate Drug: Betaine Drug: Choline bitartrate + Betaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pilot Study of Choline and Betaine Supplementation in Arsenic-exposed Individuals in Bangladesh
Study Start Date : December 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arsenic

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo tablets
Other: Placebo
Experimental: Choline bitartrate
Choline bitartrate 700 mg by mouth daily
Drug: Choline bitartrate
Experimental: Betaine
Betaine 1000 mg by mouth daily
Drug: Betaine
Experimental: Choline bitartrate + Betaine
Choline bitartrate 700 mg + Betaine 1000 mg daily
Drug: Choline bitartrate + Betaine

Primary Outcome Measures :
  1. Change in Urinary % Monomethyl Arsenic [ Time Frame: From baseline to 8 weeks after the start of the intervention (week 8 - baseline) ]
  2. Change in Urinary % Inorganic Arsenic [ Time Frame: From baseline to 8 weeks after the start of the intervention (week 8 - baseline) ]
  3. Change in Urinary % Dimethyl Arsenic [ Time Frame: From baseline to 8 weeks after the start of the intervention (week 8 - baseline) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 20-65
  • Absence of all exclusion criteria

Exclusion Criteria:

  • women who are currently pregnant at the time of recruitment and/or plan to become pregnant within 2 months
  • individuals taking nutritional supplements at the time of recruitment
  • individuals who have taken nutritional supplements within the last 3 months
  • participants enrolled in any other clinical trial
  • women who are currently breastfeeding
  • individuals known to have coronary heart disease, cerebrovascular disease, hypertension, renal disease, chronic obstructive pulmonary disease, asthma, cancer, or liver disease
  • participants with protein or glucose in their urine sample (dipstick test)
  • individuals whose drinking water history is complete for < 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01749982

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Columbia University Arsenic Research Project
Dhaka, Bangladesh
Sponsors and Collaborators
Columbia University
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Principal Investigator: Megan N Hall, ScD Columbia University

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Responsible Party: Megan Hall, Assistant Professor of Epidemiology, Columbia University Identifier: NCT01749982    
Other Study ID Numbers: AAAJ1959
First Posted: December 17, 2012    Key Record Dates
Results First Posted: August 28, 2014
Last Update Posted: August 28, 2014
Last Verified: August 2014
Keywords provided by Megan Hall, Columbia University:
Additional relevant MeSH terms:
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Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents